Carbomedics Valve Tester
FDA 510(k) K960169 · Carbomedics, Inc.
510(k) numberK960169
Submission
- Device name
- Carbomedics Valve Tester
- Applicant
- Carbomedics, Inc.
Austin, TX, US - Received
- January 16, 1996
- Decision date
- April 15, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTJ – Holder, Heart-Valve, Prosthesis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.3935
- Specialty
- Cardiovascular
Other 510(k)s with product code DTJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962154 | Carbomedics HandleDTJ · Traditional | Carbomedics, Inc. | 08/27/1996SE |
| K944214 | Baxter Handle Model 1150DTJ · Traditional | Baxter Edwards | 02/10/1995SE |
| K942736 | Carbomedics(R) Prosthetic Heart Valve Holder HandleDTJ · Traditional | Carbomedics, Inc. | 07/06/1994SE |
| K880052 | Edwards-Duromedics Mitral Valve RotatorDTJ · Traditional | Baxter Healthcare Corp | 04/01/1988SE |
| K871596 | Ionescu-Shiley Pericardial Xenograft (Isu)DTJ · Traditional | Shiley, Inc. | 06/15/1987SE |
| K864155 | Modification of Carpentier-Edwards BioprosthesisDTJ · Traditional | American Edwards Laboratories | 11/20/1986SE |
| K813276 | Ionescu-Shiley Valve Holder & HandleDTJ · Traditional | Shiley, Inc. | 12/10/1981SE |
| K811236 | Disposable Holder for Hancock AorticDTJ · Traditional | Vascor, Inc. | 05/13/1981SE |
| K811235 | Disposable Holder for Hancock MitralDTJ · Traditional | Vascor, Inc. | 05/13/1981SE |
| K792034 | Integral Disposable Holder CarpentierDTJ · Traditional | Edwards Laboratories | 12/07/1979SE |
More from Edwards Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K970375 | Annuloflo SystemKRH · Traditional | 07/25/1997ST |
| K964665 | Vascutek Gelweave Vascular Graft (Bifurcated Configuration)DSY · Traditional | 02/19/1997ST |
| K962154 | Carbomedics HandleDTJ · Traditional | 08/27/1996SE |
| K960923 | Carbomedics Mitral RotatorMOP · Traditional | 04/29/1996SE |
| K960706 | Vascutek Vascusoft Plus Vascular GraftDSY · Traditional | 04/25/1996SESP |
| K955588 | Vascutek Graft Sizer SetDSY · Traditional | 03/07/1996ST |
| K952184 | Carbomedics Supra-Annular Valve SizerDTI · Traditional | 11/29/1995SE |
| K951368 | Carbomedics Exended Mitral RotatorMOP · Traditional | 06/20/1995SE |
| K942736 | Carbomedics(R) Prosthetic Heart Valve Holder HandleDTJ · Traditional | 07/06/1994SE |
| K934951 | Valve SizerDTI · Traditional | 12/10/1993SE |
Questions and answers
When was Carbomedics Valve Tester cleared by the FDA?
Carbomedics Valve Tester (K960169) received a 510(k) decision of Substantially Equivalent on April 15, 1996, 90 days after the submission was received.
What is the product code of K960169?
The FDA product code is DTJ – Holder, Heart-Valve, Prosthesis, a Class I (low risk) device regulated under 21 CFR 870.3935.